Video Adapter

FDA UDI

Class II (US FDA UDI)

by Olympus Medical Systems Corporation

Identity

Trade Name: Video Adapter FDA UDI
Generic Name: Endoscope camera adaptor FDA UDI
Device Name: AR-TL08E ADAPTER OTV-S5 ROTATABLE .8X FDA UDI
Model / Reference: OLYMPUS AR-TL08E FDA UDI
Description: AR-TL08E ADAPTER OTV-S5 ROTATABLE .8X FDA UDI

Identifiers

Catalog Number: 4624030 FDA UDI
Primary DI / UDI-DI: 04953170023972 FDA UDI
510(k) Number: K971416 FDA UDI
FDA Product Code: FET FDA UDI
GMDN Term: Endoscope camera adaptor FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1500 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Endoscope camera adaptor

Video Adapter by Olympus Medical Systems Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K971416 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Olympus Medical Systems Corporation

Sources (1)

FDA UDI 9c2bd831-6abd-45c8-bc4f-abb2c8c4d494 36 fields · synced Jun 6, 2026